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Experimental menopause drug cuts number of hot flushes

Phase II study reports significant reduction in menopausal symptoms in women who took neurokinin 3 receptor antagonist MLE4901.

An experimental drug has been shown to dramatically cut the number of hot flushes in women with severe menopause symptoms.

In a phase II randomised trial of the neurokinin 3 receptor antagonist MLE4901 in 28 women aged 40-62 years who had seven or more hot flushes a day, a significant reduction in symptoms was found in women who took the drug.

MLE4901 cut the frequency of flushes by 45 percentage points, and symptom severity by 41 percentage points, between the week before the study began and week four of treatment.

The trial was designed as a placebo-controlled crossover study, so women taking part took the test drug followed by placebo, or placebo followed by the test drug, and acted as their own controls. The research team at Imperial College London, which conducted the study, said the treatment seemed to be “pretty life-changing”.

Women experienced a 73% drop in symptom frequency compared with baseline levels when taking MLE4901 – which works to block the action of neurokinin B, a chemical implicated in menopausal flushing. Meanwhile, women taking the placebo pills experienced a 28% reduction in symptom frequency.

The study, which was funded by the UK Medical Research Council and the National Institute for Health Research, and published in The Lancet[1], also showed the drug — originally developed by AstraZeneca — reduced the impact of flushes on participants’ daily life.

Professor Waljit Dhillo, an NIHR research professor from the Department of Medicine at Imperial College London, says the drug could be a “game-changer” for women having more than seven hot flushes a day.

“For day-to-day living and work, that’s a significant impact on quality of life.”

Women taking part in the trial said they felt “human again”, says study leader Julia Prague. “Despite the fact that for millions of women their menopausal symptoms are intolerable, so many are suffering in silence because it is a taboo subject and treatment options are limited.”

Once the drug is tested in a larger study, it is hoped to become an alternative for hormone replacement therapy, which some patients are advised against taking because of the increased risk of breast cancer and blood clots.

Professor Mary Ann Lumsden, senior vice president of the Royal College of Obstetricians and Gynaecologists, says that the study is welcome news for women going through the menopause, but “it is a relatively small trial and further research is needed”.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202572

Readers' comments (1)

  • Thanks for the article, and this space.
    Quoted from Wikipedia, following are some neuokinin effects-among a few more, that are pertinent to what I experienced in my unprecedented menopause!
    "• regulation of uterine smooth muscle contraction
    • response to pain
    • detection of abiotic stimulus
    • inflammatory response
    • positive regulation of smooth muscle contraction
    • aggressive behavior
    • angiotensin-mediated drinking behavior
    • learning or memory
    • long-term memory
    • regulation of blood pressure
    • associative learning
    • response to heat
    • response to auditory
    • sensory perception of pain
    operant conditioning
    • positive regulation of renal sodium excretion
    • eating behavior
    • positive regulation of vascular permeability
    • positive regulation of blood pressure
    • positive regulation of saliva secretion
    • behavioral response to pain
    • positive regulation of stress fiber assembly
    • smooth muscle contraction involved in micturition
    • positive regulation of uterine smooth muscle contraction"
    In brief, i will v briefly summarize those, respectively to the above, given I had much more diverse symptoms reaching to seizures, gasping, and opisthotonus posturing like in strychnine poisoning. This would attest to the role of this neurokinin molecule in menopause, and the impact of blocking its receptors in ameliorating hot flashes symptoms, evidently if benefits exceed harmful side effects( keeping in mind positive beneficial effect of this molecule on other vital biological function).
    In brief, I had:
    -Recurrent uterine cramps like in labor pain( which I knew well in my four childbirth experiences), exerting indescribable pain.
    Repeated bouts of excruciating restless leg syndrome manifestations, and equally excruciating spasms at the slightest movement, even prohibitive of essential movements at toilet activity.
    Dystoinc postures, and facial and palm twitching, were frequent.
    -Invariably I would go lunatic at the wave of pain sensation in a hot flash, and I go restless and aggressive, like in rabies!
    -Thirst was extreme, horrific and voracious, that glutting 3 glasses at a draught would hardly be sensed by my burning brain.
    -My neuropathic pain induced by a flash was horrific, encompassing all my body parts, to the tip of my toes, and encompassing all literature description, like electrifying, burning, biting, mincing, stabbing, drawing, pressing, pricking, and prickling, to the milder yet v tantalizing formication, tingling, itching-often voluptuous, and more. Herein, the slightest pain stimulus would reverberate, and trigger a repeated pain response that typically-unusual to normal people response-lasts long.
    -Exposure to sunlight was intolerable, the faintest sound was irritating to my rampant ears, and exposure to cool air, would trigger exaggerated pain sensation; notoriously I would invariably be forced to cover my feet while paradoxically uncovering my burning body.
    The slightest touch-for a hug, was painful, and even the touch of water was unbearable, literally.
    -Diuresis was typical after an acute flash resolution, outside and separate from effect of the latter on my urinaty bladder.
    -Initially I had vanquishing nausea, and recalcitrant vomiting, and gradually upon further hot flash consumption, would have, patadoxically, bouts of voracious food intake, and craving for especially chocolate.
    - Drooling saliva was not infrequent at night, and choking and cough were markers, while at the outset of cryptic flashes, I would have weird sensation of food rejection by my guts at the mere first introduction of the first bite.
    -I had repeated rashes, and exaggerated dermatographism, especially on harsh flash days.
    -Often, initially, I would be desperately fetching the rigt word for a meaning, only to resort to a synonym, as my brain would be in "haze", at a flash. At the pinnacle of my hot flash surges, I was in fog, almost literally.
    -My blood pressure would notoriously rise, to around 160/100 within flashes, and then return to 130/85-90 thereafter.
    -I had what was like a neuropathic bladder; sensation of fullness while the bladder contraction would be totally obliterated, or the urine stream would be like a dripping tap.
    Menopause is a great mimic of all diseases, thanks to neurokinin, behind which lies estrogen!
    Dr Hana Fayyad, pediatrician
    ( Maria Jasmine Freeman).

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